广东11选5

广东11选5

ZAIXIANKEFU

2019年国家药监局关于发布国家医疗器械监督抽检结果的通告(第5号)

  为加强医疗器械质量监督管理,保障医疗器械产品使用安全有效,国家药品监督管理局组织对血液透析器、血液透析设备、外科缝线(针)等29个品种共965批(台)产品进行了质量监督抽检。具体情况通告如下:

 

  BEICHOUJIANXIANGMUBUFUHEBIAOZHUNGUIDINGDEYILIAOQIXIECHANPIN,SHEJI57JIAQIYEDE16GEPINZHONG61PI(TAI)。JUTIWEI:

 

  (YI)FUBUCHUANCIQI2JIAQIYE2PICICHANPIN。HANGZHOUTONGLUYILIAOGUANGXUEYIQIYOUXIANGONGSISHENGCHANDE1PICIFUQIANGJINGPEITAOSHOUSHUQIXIE(CHUANCIQI),MIFENGXINGHEZUQIXING、YINGDUBUFUHEBIAOZHUNGUIDING;TONGLUKANGERYILIAOQIXIEYOUXIANGONGSISHENGCHANDE1PICIYICIXINGSHIYONGFUQIANGJINGYONGCHUANCIQI,PEIHEXINGNENGBUFUHEBIAOZHUNGUIDING。

 

  (ER)GAODIANWEIZHILIAOSHEBEI4JIAQIYE4TAICHANPIN。CHUZHOUGUOKANGYILIAOYIQIYOUXIANGONGSISHENGCHANDE1TAIGAODIANWEIZHILIAOYI,SUIJIWENJIAN、WAIQIAOHEFANGHUZHAO、SHUCHUDIANYABUFUHEBIAOZHUNGUIDING;ZHUSHIHUISHELIBAISHI(DAILISHANG:SHANGHAIRICHENYILIAOQIXIEYOUXIANGONGSI)SHENGCHANDE1TAIGAOYADIANWEIZHILIAOYI,ZHISHIDENGHEANNIU、SHUCHUDIANYA、SHUCHUPINLVBUFUHEBIAOZHUNGUIDING;SUZHOUJIUJIUSHOUYILIAOQIXIEYOUXIANGONGSISHENGCHANDE1TAIGAOYADIANWEIZHILIAOYI,JIEGOUHEBUXIANBUFUHEBIAOZHUNGUIDING;NANJINGTANGWOYILIAOKEJIYOUXIANGONGSISHENGCHANDE1TAIGAOYADIANWEIZHILIAOYI,SUIJIWENJIANBUFUHEBIAOZHUNGUIDING。

 

广东11选5  (SAN)KUANGUANJIEJIATI1JIAQIYE1PICICHANPIN。TIANXINFU(BEIJING)YILIAOQICAIGUFENYOUXIANGONGSISHENGCHANDE1PICIKUANGUANJIEJIATI(GUGEMU)GUGEMUGUGUBING、KUANGUANJIEJIATI(GUGEMU)GUGEMUGUGUTOU,GUGUQIUTOUZHUILIANJIEDEZHIJING、ZHUIDU、ZHIXIANDUHEYUANDUBUFUHEBIAOZHUNGUIDING。

 

  (SI)LIANXUXINGXUEYEJINGHUASHEBEI1JIAQIYE1TAICHANPIN。Infomed S.A.(DAILISHANG:GUANGZHOUDELANGYILIAOSHEBEIYOUXIANGONGSI)SHENGCHANDE1TAILIANXUXINGXUEYEJINGHUASHEBEI,JINGMAIYAJIANKONGBUFUHEBIAOZHUNGUIDING。

 

广东11选5  (WU)RUANXINGJIECHUJING2JIAQIYE2PICICHANPIN。Vision Science Co,Ltd.(DAILISHANG:KEERSHIYILIAOQIXIE(SHANGHAI)YOUXIANGONGSI)SHENGCHANDE1PICIRUANXINGQINSHUIJIECHUJING,ZHESHELVBUFUHEBIAOZHUNGUIDING;SEED Co.,Ltd.(DAILISHANG:SHITONG(SHANGHAI)SHANGMAOYOUXIANGONGSI)SHENGCHANDE1PICIRUANXINGQINSHUIJIECHUJINGSoft Hydrophilic Contact Lenses,ZONGZHIJINGBUFUHEBIAOZHUNGUIDING。

 

广东11选5  (LIU)TEDINGDIANCIBOZHILIAOYI5JIAQIYE5TAICHANPIN。SICHUANHENGMINGKEJIKAIFAYOUXIANGONGSISHENGCHANDE1TAITEDINGDIANCIBOPUZHILIAOQI,FANGHUJIAN、FANGHUZHAODEBIAOMIANRONGXUDEZUIGAOWENDUBUFUHEBIAOZHUNGUIDING;ZHONGQINGGEJIASHANGMAOYOUXIANGONGSISHENGCHANDE1TAITEDINGDIANCIBO(TDP)ZHILIAOQI,KONGZHIQIDECAOZUOBUJIAN、ZHENGCHANGSHIYONGSHIDEWENDINGXINGBUFUHEBIAOZHUNGUIDING;ZHONGQINGPINGFENGJIXIEYOUXIANGONGSI、ZHONGQINGXINSHANGYILIAOQIXIEYOUXIANGONGSISHENGCHANDEGE1TAITEDINGDIANCIBOZHILIAOQI,KONGZHIQIDECAOZUOBUJIANBUFUHEBIAOZHUNGUIDING;ANHUILEJINJIANKANGKEJIGUFENYOUXIANGONGSISHENGCHANDE1TAIHONGWAIPINPULILIAOZHUANGZHI,SUIJIWENJIAN(GB 9706.1-2007、YY 0306-2008)BUFUHEBIAOZHUNGUIDING。

 

  (QI)TIANRANJIAORUXIANGJIAOBIYUNTAO6JIAQIYE7PICICHANPIN。JININGWEIKANGJIAOYEYOUXIANGONGSISHENGCHANDE1PICITIANRANJIAORUXIANGJIAOBIYUNTAO,WEIJINGLAOHUABAOPOTIJIHEBAOPOYALI、ZHENKONGBUFUHEBIAOZHUNGUIDING;HEZEKANGSHENYAOYEYOUXIANGONGSISHENGCHANDE2PICI、GAOPINGSHIDANYANGXIANGJIAOZHIPINYOUXIANGONGSI、MAOMINGSHIJIANGYUANRUJIAOZHIPINYOUXIANGONGSISHENGCHANDEGE1PICITIANRANJIAORUXIANGJIAOBIYUNTAO,WEIJINGLAOHUABAOPOTIJIHEBAOPOYALIBUFUHEBIAOZHUNGUIDING;Suretex Prophylactics (lndia) Limited(DAILISHANG:WUHANJIESHIBANGWEISHENGYONGPINYOUXIANGONGSIXIANNINGFENGONGSI)、MALAIXIYAYINGNUOLEITEXIANGJIAOGONGYEYOUXIANGONGSI(DAILISHANG:TIANJIGUOJIMAOYI(SHANGHAI)YOUXIANGONGSI)SHENGCHANDEGE1PICITIANRANJIAORUXIANGJIAOBIYUNTAO,ZHENKONGBUFUHEBIAOZHUNGUIDING。

 

广东11选5  (BA)WAIKEFENGXIAN(ZHEN)7JIAQIYE7PICICHANPIN。NINGBOSHICHENGHEXIANWEIQIXIECHANGSHENGCHANDE1PICIDAIXIANFENGHEZHEN、Arthrex,Inc.(DAILISHANG:RUISHIYILIAOQIXIE(SHANGHAI)YOUXIANGONGSI)SHENGCHANDE1PICIFEIXISHOUXINGWAIKEFENGXIAN、SUZHOUSHIJIASHENGYILIAOYONGPINYOUXIANGONGSISHENGCHANDE1PICIFEIXISHOUXINGWAIKEFENGXIAN(CANSIXIAN)、Ethicon LLC(DAILISHANG:QIANGSHENG(SHANGHAI)YILIAOQICAIYOUXIANGONGSI)SHENGCHANDE1PICIJUZHIBUKEXISHOUFENGHEXIAN、ETHICON,LLC(DAILISHANG:QIANGSHENG(SHANGHAI)YILIAOQICAIYOUXIANGONGSI)SHENGCHANDE1PICIKEXISHOUXINGFENGXIAN、JIANGSUMINGHUANYIYONGPINYOUXIANGONGSISHENGCHANDE1PICIDAIXIANFENGHEZHEN,FENGXIANXIANJINGBUFUHEBIAOZHUNGUIDING;SHANGHAIYUANHONGYILIAOQIXIEYOUXIANGONGSISHENGCHANDE1PICIDAIXIANFENGHEZHEN(YIYONGDILUNBIANZHIXIAN),ZHENXIANLIANJIEQIANGDUBUFUHEBIAOZHUNGUIDING。

 

  (JIU)WEIBOZHILIAOSHEBEI4JIAQIYE5TAICHANPIN。GUANGDONGKANGYEYILIAOSHEBEIYOUXIANGONGSISHENGCHANDE1TAIWEIBOZHILIAOYI,SHURUGONGLV、ZHENGCHANGGONGZUOWENDUXIADELIANXULOUDIANLIUHEHUANZHEFUZHUDIANLIUBUFUHEBIAOZHUNGUIDING;ZHONGQINGSHUMINGKEJIFAZHANYOUXIANGONGSISHENGCHANDE1TAIWEIBOZHILIAOJI,SUIJIWENJIANBUFUHEBIAOZHUNGUIDING;NANJINGFUZHONGYILIAOGAOKEYOUXIANGONGSISHENGCHANDE1TAIWEIBOZHILIAOYI、NANJINGWEIJINGJIUZHOUYILIAOQIXIEYANFAZHONGXINSHENGCHANDE1TAIWEIBOZHILIAOYIHE1TAIWEIBOXIAORONGZHILIAOYI,ZHENGCHANGGONGZUOWENDUXIADELIANXULOUDIANLIUHEHUANZHEFUZHUDIANLIUBUFUHEBIAOZHUNGUIDING。

 

  (SHI)XUEYETOUXIQI1JIAQIYE1PICICHANPIN。BEIENYILIAOSHEBEI(GUANGZHOU)YOUXIANGONGSISHENGCHANDE1PICIKONGXINXIANWEIXUEYETOUXIQI,QINGCHULVBUFUHEBIAOZHUNGUIDING。

 

广东11选5  (SHIYI)XUEYETOUXISHEBEI1JIAQIYE1TAICHANPIN。ZHONGQINGAOKAILONGYILIAOKEJIGUFENYOUXIANGONGSISHENGCHANDE1TAIXUEYETOUXIJI,ZHENGCHANGJIANYANGUOCHENGZHONGKAIJIWUFAZHENGCHANGSHIYONG,BUFUHEBIAOZHUNGUIDING。

 

广东11选5  (SHIER)YAKEGUANGGUHUAJI7JIAQIYE7TAICHANPIN。FOSHANSHIANDAKEJIYOUXIANGONGSISHENGCHANDE1TAILEDGUANGGUHUAJI,ZHENGCHANGGONGZUOWENDUXIADELIANXULOUDIANLIUHEHUANZHEFUZHUDIANLIU、ZHISHIQIBUFUHEBIAOZHUNGUIDING;COLT?NE/WHALEDENT INC.(DAILISHANG:KANGTEWEIERDENGTECHIKEMAOYI(BEIJING)YOUXIANGONGSI)SHENGCHANDE1TAILEDGUANGGUHUAJI、FOSHANSHINANHAIQUJINGYACHIKEQICAIYOUXIANGONGSISHENGCHANDE1TAIGUANGGUHUAJI、DENTLIGHT INC.(DAILISHANG:BEIJINGGUQIKOUQIANGKEJIYOUXIANGONGSI)HEFOSHANSHIXINAIDEYILIAOQIXIEYOUXIANGONGSISHENGCHANDEGE1TAIYAKEGUANGGUHUAJI,ZHENGCHANGGONGZUOWENDUXIADELIANXULOUDIANLIUHEHUANZHEFUZHUDIANLIUBUFUHEBIAOZHUNGUIDING;FOSHANSHIYUSENYILIAOQIXIEYOUXIANGONGSISHENGCHANDE1TAILEDGUANGGUHUAJI、BEISIDEERYILIAOQICAI(GUANGZHOU)YOUXIANGONGSISHENGCHANDE1TAIGUANGGUHUAJI,ZHISHIDENGHEANNIUBUFUHEBIAOZHUNGUIDING。

 

  (SHISAN)YICIXINGSHIYONGBIANXIESHISHUZHUBENGFEIDIANQUDONG4JIAQIYE4PICICHANPIN。JIANGSUSHENGHUAXINGYILIAOQIXIESHIYEYOUXIANGONGSI、NANJINGYANGZIYIYONGZHIPINYOUXIANGONGSI、NANJINGNINGCHUANGYILIAOSHEBEIYOUXIANGONGSI、SHANDONGTIANGONGYIYONGPINKAIFAYOUXIANGONGSISHENGCHANDEGE1PICIYICIXINGSHIYONGSHUZHUBENG,ZIWAIXIGUANGDUBUFUHEBIAOZHUNGUIDING。

 

  (SHISI)YICIXINGSHIYONGWUJUNDAONIAOGUAN1JIAQIYE1PICICHANPIN。HAERBINJISHENGKEJIFAZHANYOUXIANGONGSIYILIAOQIXIEFENGONGSISHENGCHANDE1PICIYICIXINGSHIYONGWUJUNDAONIAOBAO,EOCANLIULIANGBUFUHEBIAOZHUNGUIDING。

 

  (SHIWU)YICIXINGSHIYONGYIYONGKOUZHAO7JIAQIYE9PICICHANPIN。HENANRUIKEYILIAOQIXIEYOUXIANGONGSISHENGCHANDE1PICIYICIXINGSHIYONGYIYONGKOUZHAO,KOUZHAODAI、XIJUNGUOLVXIAOLV(BFE)BUFUHEBIAOZHUNGUIDING;HENANSHENGHUAYUYILIAOQIXIEYOUXIANGONGSIHEXINXIANGSHIYIBANGWEISHENGCAILIAOYOUXIANGONGSISHENGCHANDEGE1PICIYICIXINGSHIYONGYIYONGKOUZHAO、XINXIANGSHIDAFANGYILIAOQIXIEZHIZAOYOUXIANGONGSISHENGCHANDE2PICIYIYONGKOUZHAO,KOUZHAODAIBUFUHEBIAOZHUNGUIDING;HENANSHENGYUBEIWEICAIYOUXIANGONGSIHENANCHANGSHIKAIXUANYILIAOQIXIEYOUXIANGONGSISHENGCHANDEGE1PICIYICIXINGSHIYONGYIYONGKOUZHAO、SHAOYANGZHIKANGYILIAOQIXIEYOUXIANGONGSISHENGCHANDE2PICIYICIXINGSHIYONGYIYONGKOUZHAO,XIJUNGUOLVXIAOLV(BFE)BUFUHEBIAOZHUNGUIDING。

 

  (SHILIU)YIYONGWAIKEKOUZHAO4JIAQIYE4PICICHANPIN。SUZHOUXINLUNCHAOJINGJISHUYOUXIANGONGSISHENGCHANDE1PICIYIYONGWAIKEKOUZHAO,KOUZHAODAIBUFUHEBIAOZHUNGUIDING;WUJIANGSHIYICHENGYILIAOQIXIEYOUXIANGONGSISHENGCHANDE1PICIYICIXINGSHIYONGYIYONGWAIKEKOUZHAO、HENANSHENGLANTIANYILIAOQIXIEYOUXIANGONGSIHENANCHANGWEICAIYILIAOQIXIEYOUXIANGONGSISHENGCHANDEGE1PICIYIYONGWAIKEKOUZHAO,YALICHA(Δp)BUFUHEBIAOZHUNGUIDING。

 

  以上抽检不符合标准规定产品具体情况,见附件1。

 

广东11选5  ER、BEICHOUJIANXIANGMUWEIBIAOSHIBIAOQIAN、SHUOMINGSHUDENGXIANGMUBUFUHEBIAOZHUNGUIDINGDEYILIAOQIXIECHANPIN,SHEJI11JIAQIYEDE6GEPINZHONG12TAI,JUTIWEI:

 

  (YI)GAODIANWEIZHILIAOSHEBEI3JIAQIYE3TAICHANPIN。CHUZHOUGUOKANGYILIAOYIQIYOUXIANGONGSISHENGCHANDE1TAIGAODIANWEIZHILIAOYI、SUZHOUJIUJIUSHOUYILIAOQIXIEYOUXIANGONGSISHENGCHANDE1TAIGAOYADIANWEIZHILIAOYI,KONGZHIQIHEYIBIAODEBIAOJIBUFUHEBIAOZHUNGUIDING;NANJINGTANGWOYILIAOKEJIYOUXIANGONGSISHENGCHANDE1TAIGAOYADIANWEIZHILIAOYI,SHEBEIHUOSHEBEIBUJIANDEWAIBUBIAOJIBUFUHEBIAOZHUNGUIDING。

 

广东11选5  (ER)LIANXUXINGXUEYEJINGHUASHEBEI1JIAQIYE1TAICHANPIN。Infomed S.A.(DAILISHANG:GUANGZHOUDELANGYILIAOSHEBEIYOUXIANGONGSI)SHENGCHANDE1TAILIANXUXINGXUEYEJINGHUASHEBEI,SHEBEIHUOSHEBEIBUJIANDEWAIBUBIAOJIBUFUHEBIAOZHUNGUIDING。

 

  (SAN)TEDINGDIANCIBOZHILIAOYI1JIAQIYE1TAICHANPIN。SICHUANHENGMINGKEJIKAIFAYOUXIANGONGSISHENGCHANDE1TAITEDINGDIANCIBOPUZHILIAOQI,SHEBEIHUOSHEBEIBUJIANDEWAIBUBIAOJI、JINGSHIBIAOJIBUFUHEBIAOZHUNGUIDING。

 

  (SI)WEIBOZHILIAOSHEBEI3JIAQIYE4TAICHANPIN。NANJINGWEIJINGJIUZHOUYILIAOQIXIEYANFAZHONGXINSHENGCHANDE1TAIWEIBOXIAORONGZHILIAOYI,SHEBEIHUOSHEBEIBUJIANDEWAIBUBIAOJI、SHEBEIDEWAIBUBIAOJIBUFUHEBIAOZHUNGUIDING;ZHONGQINGSHUMINGKEJIFAZHANYOUXIANGONGSISHENGCHANDE1TAIWEIBOZHILIAOJI、NANJINGFUZHONGYILIAOGAOKEYOUXIANGONGSIHENANJINGWEIJINGJIUZHOUYILIAOQIXIEYANFAZHONGXINSHENGCHANDEGE1TAIWEIBOZHILIAOYI,SHEBEIHUOSHEBEIBUJIANDEWAIBUBIAOJIBUFUHEBIAOZHUNGUIDING。

 

广东11选5  (WU)WUCHUANGZIDONGCELIANGXUEYAJI(DIANZIXUEYAJI)1JIAQIYE1TAICHANPIN。SHENZHENSHILEZHONGXINGKEJIYOUXIANGONGSISHENGCHANDE1TAISHOUBEISHIDIANZIXUEYAJI,BIAOSHIYAOQIUBUFUHEBIAOZHUNGUIDING。

 

广东11选5  (LIU)YAKEGUANGGUHUAJI2JIAQIYE2TAICHANPIN。BEISIDEERYILIAOQICAI(GUANGZHOU)YOUXIANGONGSISHENGCHANDE1TAIGUANGGUHUAJI、DENTLIGHT INC.(DAILISHANG:BEIJINGGUQIKOUQIANGKEJIYOUXIANGONGSI)SHENGCHANDE1TAIYAKEGUANGGUHUAJI,SHEBEIHUOSHEBEIBUJIANDEWAIBUBIAOJIBUFUHEBIAOZHUNGUIDING。

 

  以上抽检不符合标准规定产品具体情况,见附件2。

 

  三、抽检项目全部符合标准规定的医疗器械产品涉及419家企业的23个品种903批(台),见附件3。

 

  SI、DUISHANGSHUCHOUJIANZHONGFAXIANDEBUFUHEBIAOZHUNGUIDINGCHANPIN,GUOJIAYAOPINJIANDUGUANLIJUYIYAOQIUQIYESUOZAIDISHENGJIYAOPINJIANDUGUANLIBUMENDUCUXIANGGUANQIYEANZHAO《YILIAOQIXIEJIANDUGUANLITIAOLI》《YILIAOQIXIEZHAOHUIGUANLIBANFA》DENGFAGUIGUIZHANGYAOQIUDUICHOUJIANBUFUHEBIAOZHUNGUIDINGDECHANPINJINXINGFENGXIANPINGGU,GENJUYILIAOQIXIEQUEXIANDEYANZHONGCHENGDUQUEDINGZHAOHUIJIBIE,ZHUDONGZHAOHUICHANPINBINGGONGKAIZHAOHUIXINXI。TONGSHI,QIYEYINGJINKUAICHAMINGCHANPINBUHEGEYUANYIN,ZHIDINGZHENGGAICUOSHIBINGANQIZHENGGAIDAOWEI,YOUGUANCHUZHIQINGKUANGYU2019NIAN7YUE10RIQIANXIANGSHEHUIGONGBU,BINGJISHIJIANGXIANGGUANQINGKUANGBAOGAOSUOZAIDISHENGJIYAOPINJIANDUGUANLIBUMEN。

 

  WU、QIYESUOZAIDISHENGJIYAOPINJIANDUGUANLIBUMENYINGDUIXIANGGUANQIYEJINXINGDIAOCHACHULI,DUIQIYEJINXINGCHANPINZHAOHUI、BUHEGEYUANYINDIAOCHA、LUOSHIZHENGGAICUOSHIJIGONGKAIPILUXINXIDENGQINGKUANGJINXINGJIANDU;RUCHANPINDUIRENTIZAOCHENGSHANGHAIHUOZHEYOUZHENGJUZHENGMINGKENENGWEIHAIRENTIJIANKANGDE,YINGYIFACAIQUZANTINGSHENGCHAN、JINGYING、SHIYONGDENGJINJIKONGZHICUOSHI;XUYAOZANTINGJINKOUDE,YINGJISHIBAOGUOJIAYAOPINJIANDUGUANLIJUZUOCHUXINGZHENGCHULIJUEDING。QIYEWEIANYAOQIULUOSHISHANGSHUYAOQIUDE,SUOZAIDISHENGJIYAOPINJIANDUGUANLIBUMENYAOYIFAYANSUCHACHU。YOUGUANXINXIYINGJISHIXIANGSHEHUIGONGKAI。

 

  LIU、YISHANGGEXIANGLUOSHIQINGKUANG,XIANGGUANSHENGJIYAOPINJIANDUGUANLIBUMENYU2019NIAN7YUE20RIQIANBAOGAOGUOJIAYAOPINJIANDUGUANLIJU。

 

  特此通告。

 

  FUJIAN:1.GUOJIAYILIAOQIXIECHOUJIANBUFUHEBIAOZHUNGUIDINGCHANPINMINGDAN

 

广东11选5  2.GUOJIAYILIAOQIXIECHOUJIAN(BIAOSHIBIAOQIANSHUOMINGSHUDENGXIANGMU)BUFUHEBIAOZHUNGUIDINGCHANPINMINGDAN

 

  3.GUOJIAYILIAOQIXIECHOUJIANFUHEBIAOZHUNGUIDINGCHANPINMINGDAN

 

GUOJIAYAOJIANJU


2019年6月24日